Arterial Biology for the Investigation of the Treatment Effects of Reducing cholesterol (ARBITER) 2: A double-blind, placebo-controlled study of extended-release niacin on atherosclerosis progression in secondary prevention patients treated with statins

Allen J. Taylor, Lance E. Sullenberger, Hyun J. Lee, Jeannie K Lee, Karen A. Grace

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822 Citations (Scopus)

Abstract

Background - Niacin reduces coronary heart disease morbidity and mortality when taken either alone or in combination with statins; however, the incremental impact of adding niacin to background statin therapy is unknown. Methods and Results - This was a double-blind randomized placebo-controlled study of once-daily extended-release niacin (1000 mg) added to background statin therapy in 167 patients (mean age 67 years) with known coronary heart disease and low levels of high-density lipoprotein cholesterol (HDL-C; <45 mg/dL). The primary end point was the change in common carotid intima-media thickness (CIMT) after 1 year. Baseline CMT (0.884±0.234 mm), low-density lipoprotein cholesterol (89±20 mg/dL), and HDL-C (40±7 mg/dL) were comparable in the placebo and niacin groups. Adherence to niacin exceeded 90%, and 149 patients (89.2%) completed the study. HDL-C increased 21% (39 to 47 mg/dL) in the niacin group. After 12 months, mean CIMT increased significantly in the placebo group (0.044±0.100 mm; P<0.001) and was unchanged in the niacin group (0.014±0.104 mm; P=0.23). Although the overall difference in IMT progression between the niacin and placebo groups was not statistically significant (P=0.08), niacin significantly reduced the rate of IMT progression in subjects without insulin resistance (P=0.026). Clinical cardiovascular events occurred in 3 patients treated with niacin (3.8%) and 7 patients treated with placebo (9.6%; P=0.20). Conclusions - The addition of extended-release niacin to statin therapy slowed the progression of atherosclerosis among individuals with known coronary heart disease and moderately low HDL-C.

Original languageEnglish (US)
Pages (from-to)3512-3517
Number of pages6
JournalCirculation
Volume110
Issue number23
DOIs
StatePublished - Dec 7 2004
Externally publishedYes

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Hydroxymethylglutaryl-CoA Reductase Inhibitors
Niacin
Secondary Prevention
Atherosclerosis
Cholesterol
Placebos
Therapeutics
Coronary Disease
Carotid Intima-Media Thickness
LDL Cholesterol
HDL Cholesterol
Insulin Resistance

Keywords

  • Atherosclerosis
  • Lipids
  • Risk factors

ASJC Scopus subject areas

  • Physiology
  • Cardiology and Cardiovascular Medicine

Cite this

@article{9b9a9790201f4c679e73625838c5d997,
title = "Arterial Biology for the Investigation of the Treatment Effects of Reducing cholesterol (ARBITER) 2: A double-blind, placebo-controlled study of extended-release niacin on atherosclerosis progression in secondary prevention patients treated with statins",
abstract = "Background - Niacin reduces coronary heart disease morbidity and mortality when taken either alone or in combination with statins; however, the incremental impact of adding niacin to background statin therapy is unknown. Methods and Results - This was a double-blind randomized placebo-controlled study of once-daily extended-release niacin (1000 mg) added to background statin therapy in 167 patients (mean age 67 years) with known coronary heart disease and low levels of high-density lipoprotein cholesterol (HDL-C; <45 mg/dL). The primary end point was the change in common carotid intima-media thickness (CIMT) after 1 year. Baseline CMT (0.884±0.234 mm), low-density lipoprotein cholesterol (89±20 mg/dL), and HDL-C (40±7 mg/dL) were comparable in the placebo and niacin groups. Adherence to niacin exceeded 90{\%}, and 149 patients (89.2{\%}) completed the study. HDL-C increased 21{\%} (39 to 47 mg/dL) in the niacin group. After 12 months, mean CIMT increased significantly in the placebo group (0.044±0.100 mm; P<0.001) and was unchanged in the niacin group (0.014±0.104 mm; P=0.23). Although the overall difference in IMT progression between the niacin and placebo groups was not statistically significant (P=0.08), niacin significantly reduced the rate of IMT progression in subjects without insulin resistance (P=0.026). Clinical cardiovascular events occurred in 3 patients treated with niacin (3.8{\%}) and 7 patients treated with placebo (9.6{\%}; P=0.20). Conclusions - The addition of extended-release niacin to statin therapy slowed the progression of atherosclerosis among individuals with known coronary heart disease and moderately low HDL-C.",
keywords = "Atherosclerosis, Lipids, Risk factors",
author = "Taylor, {Allen J.} and Sullenberger, {Lance E.} and Lee, {Hyun J.} and Lee, {Jeannie K} and Grace, {Karen A.}",
year = "2004",
month = "12",
day = "7",
doi = "10.1161/01.CIR.0000148955.19792.8D",
language = "English (US)",
volume = "110",
pages = "3512--3517",
journal = "Circulation",
issn = "0009-7322",
publisher = "Lippincott Williams and Wilkins",
number = "23",

}

TY - JOUR

T1 - Arterial Biology for the Investigation of the Treatment Effects of Reducing cholesterol (ARBITER) 2

T2 - A double-blind, placebo-controlled study of extended-release niacin on atherosclerosis progression in secondary prevention patients treated with statins

AU - Taylor, Allen J.

AU - Sullenberger, Lance E.

AU - Lee, Hyun J.

AU - Lee, Jeannie K

AU - Grace, Karen A.

PY - 2004/12/7

Y1 - 2004/12/7

N2 - Background - Niacin reduces coronary heart disease morbidity and mortality when taken either alone or in combination with statins; however, the incremental impact of adding niacin to background statin therapy is unknown. Methods and Results - This was a double-blind randomized placebo-controlled study of once-daily extended-release niacin (1000 mg) added to background statin therapy in 167 patients (mean age 67 years) with known coronary heart disease and low levels of high-density lipoprotein cholesterol (HDL-C; <45 mg/dL). The primary end point was the change in common carotid intima-media thickness (CIMT) after 1 year. Baseline CMT (0.884±0.234 mm), low-density lipoprotein cholesterol (89±20 mg/dL), and HDL-C (40±7 mg/dL) were comparable in the placebo and niacin groups. Adherence to niacin exceeded 90%, and 149 patients (89.2%) completed the study. HDL-C increased 21% (39 to 47 mg/dL) in the niacin group. After 12 months, mean CIMT increased significantly in the placebo group (0.044±0.100 mm; P<0.001) and was unchanged in the niacin group (0.014±0.104 mm; P=0.23). Although the overall difference in IMT progression between the niacin and placebo groups was not statistically significant (P=0.08), niacin significantly reduced the rate of IMT progression in subjects without insulin resistance (P=0.026). Clinical cardiovascular events occurred in 3 patients treated with niacin (3.8%) and 7 patients treated with placebo (9.6%; P=0.20). Conclusions - The addition of extended-release niacin to statin therapy slowed the progression of atherosclerosis among individuals with known coronary heart disease and moderately low HDL-C.

AB - Background - Niacin reduces coronary heart disease morbidity and mortality when taken either alone or in combination with statins; however, the incremental impact of adding niacin to background statin therapy is unknown. Methods and Results - This was a double-blind randomized placebo-controlled study of once-daily extended-release niacin (1000 mg) added to background statin therapy in 167 patients (mean age 67 years) with known coronary heart disease and low levels of high-density lipoprotein cholesterol (HDL-C; <45 mg/dL). The primary end point was the change in common carotid intima-media thickness (CIMT) after 1 year. Baseline CMT (0.884±0.234 mm), low-density lipoprotein cholesterol (89±20 mg/dL), and HDL-C (40±7 mg/dL) were comparable in the placebo and niacin groups. Adherence to niacin exceeded 90%, and 149 patients (89.2%) completed the study. HDL-C increased 21% (39 to 47 mg/dL) in the niacin group. After 12 months, mean CIMT increased significantly in the placebo group (0.044±0.100 mm; P<0.001) and was unchanged in the niacin group (0.014±0.104 mm; P=0.23). Although the overall difference in IMT progression between the niacin and placebo groups was not statistically significant (P=0.08), niacin significantly reduced the rate of IMT progression in subjects without insulin resistance (P=0.026). Clinical cardiovascular events occurred in 3 patients treated with niacin (3.8%) and 7 patients treated with placebo (9.6%; P=0.20). Conclusions - The addition of extended-release niacin to statin therapy slowed the progression of atherosclerosis among individuals with known coronary heart disease and moderately low HDL-C.

KW - Atherosclerosis

KW - Lipids

KW - Risk factors

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